IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097, Italy
NCT Number: NCT07427927
This retrospective, single-center observational study will use routinely collected perioperative data from adults undergoing surgery for symptomatic hemorrhoidal disease to identify data-driven clinical phenotypes. Unsupervised machine learning will be applied to characterize clusters of patients based on demographic, clinical, anatomical, and surgical variables. The study will explore whether the resulting phenotypes differ in operative complexity and postoperative course, and will generate hypotheses to inform future predictive models and personalized surgical planning.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
San Donato Milanese, Milan, 20097, Italy
Hemorrhoidal disease presents with heterogeneous symptom patterns, anatomical findings, and operative strategies that are not fully captured by traditional degree-based classifications. This study aims to identify latent, clinically interpretable phenotypes among surgical patients using a fully unsupervised machine learning pipeline applied to routinely collected perioperative data from a high-volume tertiary referral center.
This is a retrospective, observational analysis of de-identified institutional records. The analytic dataset will include routinely documented variables spanning baseline demographics/anthropometrics, symptom profile and relevant clinical history, operative technique and intraoperative descriptors, and routinely captured postoperative follow-up information. Data will be extracted using a predefined data dictionary and standardized preprocessing rules to support reproducibility and reduce variability in variable definitions.
The primary analytic approach will be unsupervised clustering. Variables will be cleaned and standardized prior to modeling. Dimensionality reduction will be performed using t-distributed stochastic neighbor embedding (t-SNE), initialized with principal component analysis to improve stability. Cluster discovery will then be conducted using k-means clustering on the reduced feature space. A range of cluster solutions will be explored, and the final solution will be selected using internal validity metrics (e.g., silhouette-based measures) together with assessment of clinical interpretability. Model robustness will be evaluated through repeated runs across multiple random seeds and key parameter settings to assess stability of cluster assignments.
After cluster assignment, clusters will be characterized using descriptive and comparative statistics to identify variables that most differentiate phenotypes. Post-hoc feature relevance/importance approaches will be used to explore which demographic, clinical, and surgical factors most strongly contribute to cluster formation, with emphasis on effect sizes and clinically meaningful patterns rather than hypothesis-testing alone. Findings will be used to generate hypotheses regarding phenotypes that may be associated with greater operative complexity and different postoperative trajectories, supporting future work on predictive modeling and individualized surgical decision support.
All analyses will be conducted within a controlled institutional environment using validated statistical and data-mining software, with documented parameter settings and version tracking to enable reproducibility. Only de-identified data will be used for analysis, and results will be reported in aggregate to protect patient privacy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
standard hemorrhoidectomy, advanced hemorrhoidectomy, prolapsectomy, Doppler-guided procedures, or combined techniques
Time frame: From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025)
Silhouette coefficient of the final k-means clustering solution derived from t-SNE-reduced perioperative data. The silhouette coefficient will be used as the primary internal validity metric to quantify cluster cohesion and separation for the selected number of clusters.
Time frame: From completion of dataset extraction/cleaning through completion of clustering robustness analyses (retrospective analysis of surgeries performed December 2024 to June 2025)
Stability of cluster assignments across multiple random seeds and t-SNE parameter settings (including perplexity), summarized by reproducibility/consistency of membership and stability of internal validity metrics across runs.
Time frame: Intraoperative (day of surgery)
Operative duration (minutes) recorded in the operative report/perioperative database; compared across identified phenotypes.
Time frame: From surgery to 6 month postoperatively
Pain intensity as documented in routine postoperative records/follow-up notes (e.g., numeric rating scale when available or clinician-documented pain status), analyzed as pain trajectory/pattern across early and intermediate follow-up and compared across clusters.
Time frame: From surgery to 1 month postoperatively (early complications) and up to 6 months postoperatively (late complications)
Any postoperative complication recorded in routine follow-up, graded according to the Clavien-Dindo system; complication rates and severity compared across clusters.
Time frame: From surgery to 1 month postoperatively
Time to return to routine activities/work when documented in follow-up notes; compared across phenotypes.
Time frame: 1 month and 6 months postoperatively
Recurrence patterns or persistence/return of hemorrhoid-related symptoms (e.g., bleeding/prolapse/other symptoms) as documented in routine follow-up and need for re-evaluation or additional intervention; compared across clusters.
Time frame: From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025)
Additional internal cluster separation metrics (e.g., measures of between-cluster separation/within-cluster dispersion as implemented in the analytic workflow) reported to support interpretability of the phenotype solution.
Time frame: Baseline (preoperative assessment) and intraoperative (day of surgery)
Differences across clusters in routinely collected demographic and clinical history variables (e.g., age, sex, BMI, comorbidity burden, medications, symptom profile, bowel habit characteristics), anatomical descriptors (when documented), and procedure type/technique selection.
Time frame: From completion of dataset extraction/cleaning through completion of post-hoc feature relevance analyses (retrospective analysis of surgeries performed December 2024 to June 2025)
Relative contribution/importance of demographic, clinical, and surgical variables to cluster formation assessed using post-hoc feature relevance approaches; used to interpret drivers of phenotype structure.
IRCCS Policlinico S. Donato
Other
Acronym: PROCTO-CLUSTER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05089500
Cardiovascular Diseases, Digestive System Diseases
Wuhan, Hubei, China
View Trial DetailsNCT07719881
Cardiovascular Diseases, Digestive System Diseases
Palma de Mallorca, Balearic Islands, Spain
View Trial DetailsNCT06794151
Cardiovascular Diseases, Digestive System Diseases
China, Chongqing Municipality
View Trial DetailsNCT07714122
Cardiovascular Diseases, Digestive System Diseases
Cairo, Al-Manial, Cairo, Egypt, Egypt
View Trial Details